A Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT02694718|
Recruitment Status : Completed
First Posted : February 29, 2016
Results First Posted : November 9, 2016
Last Update Posted : January 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Drug: Capecitabine Drug: Oxaliplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||November 2006|
Eligible participants received capecitabine 1000 milligrams per square meter (mg/m^2) on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Capecitabine is available as 50 mg and 500 mg tablets. It will be administered as a 1000mg/m^2 bid orally on Days 1-14, and at a dose of 825mg/m^2 bid on Days 22-35 and 43-56.
Other Name: Xeloda, Ro09-1978
Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m^2/d intravenously on Day 1 and 50mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy up to Week 9 followed by surgery period.
Other Name: Eloxatin
- Percentage of Participants With Pathological Complete Tumor Response [ Time Frame: Up to Week 16 ]Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response).
- Percentage of Participants With Sphincter-preservation [ Time Frame: Up to Week 16 ]Percentage of participants with sphincter-preservation is reported.
- Number of Participants With Marked Laboratory Abnormalities [ Time Frame: Up to Week 16 ]Number of participants with marked laboratory abnormalities is reported.
- Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer [ Time Frame: Up to Week 16 ]R0 resection was defined as complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation as confirmed by pathology after pre-operative chemotherapy plus capecitabine + oxaliplatin therapy.
- Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes [ Time Frame: From screening to Week 16 ]Downstaging of primary tumor (T) and/or lymph nodes (N) was defined as decrease by 1 point in T-value and/or N-value (comparing at screening and after treatment). It was assessed by colonoscopy, pathology, endosonography of rectum, chest X-ray, abdominopelvic Computed Tomography and Magnetic Resonance Imaging. Staging for tumor are: TX (primary tumor cannot be assessed), T0 (no evidence of primary tumor), Tis (carcinoma in situ), T1 (tumor invades submucosa), T2 (tumor invades muscularis propria), T3 (tumor invades through muscularis propria into subserosa/into non-peritonealized pericolic/perirectal tissues, T4 (tumor directly invades other organs or structures). Staging for lymph nodes are: NX (regional lymph nodes cannot be assessed), N0 (no regional lymph node metastasis), N1 (metastasis in 1 to 3 regional lymph nodes), N2 (metastasis in 4 or more regional lymph nodes).
- Percentage of Participants With Pathological Incomplete Tumor Response [ Time Frame: Up to Week 16 ]Pathological incomplete tumor response was defined as grade 1 or 2 in the histological grading of regression according to Dworak grading of regression. Pathological incomplete tumor response rate, Grade 1: dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2: dominantly fibrotic changes with few tumor cells or groups (easy to find) were assessed.
- Number of Participants With Any Adverse Events and Serious Adverse Events [ Time Frame: Up to Week 16 ]An adverse event (AE) is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694718
|Basel, Switzerland, 4031|
|Chur, Switzerland, 7000|
|Luzern, Switzerland, 6004|
|St. Gallen, Switzerland, 9007|
|Zürich, Switzerland, 8037|
|Zürich, Switzerland, 8063|
|Study Chair:||Clinical Trials||Hoffmann-La Roche|